MTS Recommends... Analytical Procedure Lifecycle Management: Current Status and Opportunities

Analytical Procedure Lifecycle Management: Current Status and Opportunities

By Andy Rignall et al. in Pharmaceutical Technology, Volume 42, Issue 12, pg 18–23, Dec 02, 2018

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.

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MTS Recommends... FDA's New Data Integrity Guidance — Highlights & Observations

FDA's New Data Integrity Guidance — Highlights & Observations

By Barbara Unger, Unger Consulting Inc.
January 2, 2019

This is a very useful article that gives an overview of the main points for each of the 18 questions in the FDA guidance on data integrity.
Click here to read the article.